Busulfan and Cyclophosphamide Followed by Bone Marrow Transplantation in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

OBJECTIVES:

• Determine the remission duration, disease-free survival, and overall survival of patients with acute myelogenous leukemia in remission or early relapse or myelodysplastic syndrome treated with high-dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation.

OUTLINE: Patients receive oral high-dose busulfan every 6 hours for 14-16 doses on days -9 to -6, followed by high-dose cyclophosphamide IV over 1 hour on days -5 to -2. Allogeneic bone marrow is infused on day 0.

Patients who have already had 1 transplant receive high-dose cyclophosphamide IV on days -6 and -5, total body irradiation twice a day on days -4 to -1, and allogeneic bone marrow infusion on day 0.

All patients receive prophylaxis for graft versus host disease.

Patients are followed every 6 months for at least 2 years.

PROJECTED ACCRUAL: A total of 25-40 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Morphologically proven (from bone marrow aspirate smears or touch preps of marrow biopsy) acute myelogenous leukemia or myelodysplastic syndrome of 1 of the following subtypes:

• Acute myeloblastic leukemia (M1, M2)
• Acute promyelocytic leukemia (M3)
• Acute myelomonocytic leukemia (M4)
• Acute monocytic leukemia (M5)
• Acute erythroleukemia (M6)
• Acute megakaryocytic leukemia (M7)
• Refractory anemia
• Refractory anemia with excess blasts
• Refractory anemia with excess blasts in transformation
• Refractory anemia with ringed sideroblasts
• Chronic myelomonocytic leukemia
• In remission or in early relapse as defined by less than 20% blast cells in the marrow or overt active acute myeloid leukemia
• Suitable marrow donor, defined as a sibling donor matched at the HLA-A, HLA-B, and HLA-D/DR locus nonreactive in bidirectional mixed lymphocyte culture or a donor who is mismatched at 1 antigen loci
• Active CNS disease allowed

PATIENT CHARACTERISTICS:

Age:

• 16 to physiologic 60

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 3 times upper limit of normal (ULN) unless due to Gilbert's disease
• SGOT no greater than 3 times ULN

Renal:

• Creatinine no greater than 2.0 mg/dL

Cardiovascular:

• Cardiac ejection fraction normal

Pulmonary:

• FEV_1 at least 50% of predicted
• DLCO at least 50% of predicted

Other:

• HIV negative
• No evidence of persistent infection
• No concurrent organ damage or medical problems that would preclude study therapy

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent antibiotics